FDAJuly 12, 2019device
ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.
What to do
FDA enforcement status: Terminated
Brands named
icu medicalicu
UPCs
00840619079499
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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